Prosecution Insights
Last updated: April 19, 2026
Application No. 18/484,667

METHODS AND COMPOSITIONS FOR ADAPTIVE IMMUNE MODULATION

Non-Final OA §102§103§112§DP
Filed
Oct 11, 2023
Examiner
LEONARD, ARTHUR S
Art Unit
1631
Tech Center
1600 — Biotechnology & Organic Chemistry
Assignee
The Texas A&M University System
OA Round
1 (Non-Final)
51%
Grant Probability
Moderate
1-2
OA Rounds
3y 6m
To Grant
99%
With Interview

Examiner Intelligence

Grants 51% of resolved cases
51%
Career Allow Rate
255 granted / 503 resolved
-9.3% vs TC avg
Strong +51% interview lift
Without
With
+51.2%
Interview Lift
resolved cases with interview
Typical timeline
3y 6m
Avg Prosecution
62 currently pending
Career history
565
Total Applications
across all art units

Statute-Specific Performance

§101
3.5%
-36.5% vs TC avg
§103
39.8%
-0.2% vs TC avg
§102
17.5%
-22.5% vs TC avg
§112
21.2%
-18.8% vs TC avg
Black line = Tech Center average estimate • Based on career data from 503 resolved cases

Office Action

§102 §103 §112 §DP
Notice of Pre-AIA or AIA Status The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA . DETAILED ACTION Claim status Claims 1-19 are pending Claims 1-19 are under examination Information Disclosure Statement The information disclosure statement (IDS) submitted on 11/06/2023 and 8/27/2025 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner. However, Applicant is reminded that the listing of references in the specification is not a proper information disclosure statement. 37 CFR 1.98(b) requires a list of all patents, publications, or other information submitted for consideration by the Office, and MPEP § 609.04(a) states, "the list may not be incorporated into the specification but must be submitted in a separate paper." Therefore, unless the references have been cited by the examiner on form PTO-892, they have not been considered. Claim Objections Claim 1 is objected to because of the following informalities: instant claim uses the phrase “amount of at a composition”, which has a typographical error and should recite “amount of a composition”. Claim 16 is objected to because of the following informalities: instant claim uses the term “PAM2CSK”, which has a typographical error and should recite “PAM2CSK4”. Appropriate correction is required. Claim Rejections - 35 USC § 112(b) The following is a quotation of 35 U.S.C. 112(b): (b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention. The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph: The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention. Claim 11 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor, or for pre-AIA the applicant regards as the invention. Regarding claim 11, the phrase "such as" renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d). Appropriate correction is required. Claim Rejections - 35 USC § 102 The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action: A person shall be entitled to a patent unless – (a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale or otherwise available to the public before the effective filing date of the claimed invention. Claim 19 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by Duggan et al. (J Immun, 2011, 186:5916-5926, see IDS filed 11/06/2023). With respect to claim 19, Duggan teaches an essential sterile and microbe free pharmaceutical composition comprising a TLR9 agonist and a TLR2/6 agonist (p. 5917, Materials and Methods, Aerosolized treatments). Note that instant Claim 19 is worded such that the anti-inflammatory agents is being considered as in the alternative. Accordingly, Duggan anticipates instant claim. Claim Rejections - 35 USC § 103 The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action: A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102 of this title, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made. The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows: 1. Determining the scope and contents of the prior art. 2. Ascertaining the differences between the prior art and the claims at issue. 3. Resolving the level of ordinary skill in the pertinent art. 4. Considering objective evidence present in the application indicating obviousness or nonobviousness. This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention. Claims 1-4, 9-10, and 17-18 are rejected under 35 U.S.C. 103 as being unpatentable over Mills et al., (US2009/0176696, filed 4/18/2007, see IDS filed 11/06/2023). Mills teaches method and compositions for attenuating type I hypersensitivity (alias Th2-mediated immune responses) in a subject (Abstract, [0001]). In regard to the subject of claim 1, Mills teaches the subject suffering from the Th2 mediated disease has circulating IgE and is susceptible to allergen induced asthma ([0004, 0053-0054, 0056, 0062] see claim 5 of Mills). In regard to the composition to be administered of claim 1, Mills teaches the subject is administered compositions comprising a muropeptide and compositions comprising a combination of TLR agonists [0065, 0068-0069, 0071, 0075, 0094], see claims 9, 22 and 28 of Mills). In regard to claims 2-3, 17 and 18, Mills makes obvious that the allergen is administered in combination with the TLR agonist composition ([0166], see Example 5). In regard to claims 4 and 9-10, Mill teaches that the TLR agonists are a TLR2/1 agonist such as PAM3CSK and a TLR9 agonist such as CpG [0071, 0075]. However, Mills is silent to a preferred embodiment of a method for attenuating type I hypersensitivity in a subject susceptible to allergen induced asthma comprising administration of a combination of TLR agonists. Nevertheless, it would have been obvious to one having ordinary skill in the art at the time the invention was filed to practice said method to attenuate a type I hypersensitivity in a subject because each of the individual elements of the instant claims are independently presented by Mills as embodiments and are taught that they can be combined in various embodiments; therefore a combination of all the elements into a single embodiment would be apparent to an artisan skilled in immuno therapy in light of the Supreme Court’s KSR decision (see MPEP 2143 Exemplary Rationale (A)). Regarding the rationale for combining prior art elements according to known methods to yield predictable results, all of the claimed elements were known in the prior art and one skilled in the art could have combined the element as claimed by known methods with no change in their respective functions, and the combination would have yielded predictable results to one of ordinary skill in the art at the time of filing of the invention. Each of the elements (TLR2 agonists, TLR9 agonists, delivery methods and formulations) are taught by Mills and further they are taught in various combinations and are shown to be used in a method for attenuating a type I hypersensitivity in a subject. It would have been therefore predictably obvious to use a combination of these elements in said method. Hence, the claimed invention as a whole was prima facie obvious in the absence of evidence to the contrary. Claims 5-8, and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Mills et al., (US2009/0176696, filed 4/18/2007, see IDS filed 11/06/2023), in view of Yamazaki et al. (PLoS, 2011, 4:1-10, see IDS filed 11/06/2023) and Krishnaswamy et al. (Am J Respir Cell Mol Bio, 2012, 47:852-863) As discussed previously, Mills suggests a method and compositions for attenuating type I hypersensitivity in a subject comprising administering a combination of TLR agonists including a TLR9 agonists and the TLR2 agonist. However, Mills is silent with respect to the TLR2/6 agonist PAM2CSK4. With respect to claims 5-8 and 19, Yamazaki teaches method for activating regulatory T cells in a subject comprising administering PAM2CSK4 (Abstract, Introduction, see Fig. 3). Accordingly, it would have been prima facie obvious to one of ordinary skill in the art at the time of filing to practice a method for attenuating type I hypersensitivity in a subject comprising administering a composition comprising a combination of TLR agonists including a TLR9 agonist and TLR2 agonist as suggested by Mills and combine the TLR2/6 agonist as taught by Yamazaki with a reasonable expectation of success. The ordinary skilled artisan would have been motivated to do so as taught by Yamazaki because PAM2CSK3 is a potent activator of TREGs (Abstract & Introduction) and explicitly suggests its use for allergies (p. 6, Discussion, 3rd para.), which would have been advantageous for attenuating the type I hypersensitivity in the method of Mills. Note that Mills teaches that the activation of Th1 type responses and TREGs by TLR agonists is part of the method to attenuate the Th2 responses ([0080, 0135], see Fig. 15). In regard to the reasonable expectation of success of combining a TLR2/6 agonist in a composition for administration to a subject susceptible to allergen induced asthma, Krishnaswamy teaches methods for treating type I hypersensitivity comprising TLR2/6 agonists, wherein theTLR2/6 agonists in combination with an antigen can divert existing Th2 responses in airways cells in response to re-exposure to the allergen (Abstract, Discussion, p. 861, 1st and last para.). In regard to claim 19, as stated supra, Mills teaches the addition of the allergen with the TLR agonists, and each of the elements (TLR2/6 agonists, TLR9 agonists, and allergens) are taught by Mills et al. formulated in compositions for attenuating a type I hypersensitivity in a subject. In addition, MPEP 2144.06 indicates that “It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose.... [T]he idea of combining them flows logically from their having been individually taught in the prior art.” In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980). It would have been therefore predictably obvious to use a combination of these elements in said composition. Hence, the claimed invention as a whole was prima facie obvious in the absence of evidence to the contrary. Claims 11-13 are rejected under 35 U.S.C. 103 as being unpatentable over Mills et al., (US2009/0176696, filed 4/18/2007, see IDS filed 11/06/2023), in view of Mudde et al., (US2015/0196636, filed 7/02/2013, see IDS filed 11/06/2023). As discussed previously, Mills suggests a method for attenuating type I hypersensitivity in a subject comprising administering a combination of TLR agonists including a TLR9 agonist. However, Mills is silent with respect to the TLR9 agonist as a type C ODN such as ODNM362. Similar to Mills, Muddle teaches that allergen induced IgE-mediated immune response is characterized by a Th2 response (i.e., type I hypersensitivity) which lead to allergic reactions that can be counteracted by allergen specific IgG antibodies. Therefore, Muddle teaches that inducing a Th1 response to an allergen, rather than a Th2 helper T cell response against the allergens is beneficial for the treatment of allergic disease [0009]. Specifically, in regard to the subject, Muddle teaches that allergen hypersensitivity is allergen induced asthma [0281-0283] With respect to claims 11-13, Mudde teaches the method for attenuating type I hypersensitivity in a subject by administering a TLR9 agonist ([0039-0043, 0078, Table 1, p. 6, “Allergen” as immunogen, see claims 1, 4, and 5 of Mills), wherein theTLR9 agonist is the type C ODN such as ODNM362 ([0047, 0066, 0265, 0364, 0433-0435, 0455, 0484-0486, 0491], see claim 12 of Mudde). Accordingly, it would have been prima facie obvious to one of ordinary skill in the art at the time of filing to practice a method for attenuating type I hypersensitivity in a subject comprising administering a combination of TLR agonists including a TLR9 agonist as suggested by Mills and substitute ODNM362 as the TLR9 agonists as taught by Mudde with a reasonable expectation of success. The ordinary skilled artisan would have been motivated to do so as taught by Mudde because type C ODNs such as ODN362 are potent activator of Th1 type responses against allergies ([0066, 0490], see Table I) thereby advantageous for attenuating the Th2 type responses (i.e., type I hypersensitivity) in the method of Mills (see 0036-0040 of Mudde). Note that Mills teaches that the activation of Th1 type responses (including TREGs) by TLR agonists is part of the method to attenuate the Th2 responses ([0080, 0135], see Fig. 15). Hence, the claimed invention as a whole was prima facie obvious in the absence of evidence to the contrary. Claims 14 and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Mills et al., (US2009/0176696, filed 4/18/2007, see IDS filed 11/06/2023), in view of Yamazaki et al. (PLoS, 2011, 4:1-10, see IDS filed 11/06/2023), Krishnaswamy et al. (Am J Respir Cell Mol Bio, 2012, 47:852-863) and Mudde et al., (US2015/0196636, filed 7/02/2013, see IDS filed 11/06/2023) As discussed previously, Mills suggests a method for attenuating type I hypersensitivity in a subject comprising administering a combination of TLR agonists including TLR2 and TLR9 agonists. However, Mills is silent with respect to the TLR2/6 agonist PAM2CSK4. With respect to claim 14, Yamazaki teaches method for activating regulatory T cells in a subject comprising administering PAM2CSK4 (Abstract, Introduction, see Fig. 3). Accordingly, it would have been prima facie obvious to one of ordinary skill in the art at the time of filing to practice a method for attenuating type I hypersensitivity in a subject comprising administering a composition comprising a combination of TLR agonists including a TLR9 agonist and TLR2 agonist as suggested by Mills and combine the TLR2/6 agonist as taught by Yamazaki with a reasonable expectation of success. The ordinary skilled artisan would have been motivated to do so as taught by Yamazaki because PAM2CSK3 is a potent activator of TREGs (Abstract & Introduction) and explicitly suggests its use for allergies (p. 6, Discussion, 3rd para.), which would have been advantageous for attenuating the type I hypersensitivity in the method of Mills. Note that Mills teaches that the activation of Th1 type responses and TREGs by TLR agonists is part of the method to attenuate the Th2 responses ([0080, 0135], see Fig. 15). In regard to the reasonable expectation of success of combining a TLR2/6 agonist in a subject susceptible to allergen induced asthma, Krishnaswamy teaches methods for treating type I hypersensitivity comprising TLR2/6 agonists, wherein theTLR2/6 agonists in combination with an antigen can divert existing Th2 responses in airways cells in response to re-exposure to the allergen (Abstract, Discussion, p. 861, 1st and last para.). However with respect to claims 14 and 15, Mills is silent with respect to the TLR9 agonist ODNM362. Similar to Mills, Muddle teaches that allergen induced IgE-mediated immune response is characterized by a Th2 response (i.e., type I hypersensitivity) which lead to allergic reactions that can be counteracted by allergen specific IgG antibodies. Therefore, Muddle teaches that inducing a Th1 response to an allergen, rather than a Th2 helper T cell response against the allergens is beneficial for the treatment of allergic disease [0009]. Specifically, in regard to the subject, Muddle teaches that allergen hypersensitivity is allergen induced asthma [0281-0283] With respect to claims 14-15, Mudde teaches the method for attenuating type I hypersensitivity in a subject by administering a TLR9 agonist ([0039-0043, 0078, Table 1, p. 6, “Allergen” as immunogen, see claims 1, 4, and 5 of Mills), wherein theTLR9 agonist is the type C ODN such as ODNM362 ([0047, 0066, 0265, 0364, 0433-0435, 0455, 0484-0486, 0491], see claim 12 of Mudde). Accordingly, it would have been prima facie obvious to one of ordinary skill in the art at the time of filing to practice a method for attenuating type I hypersensitivity in a subject comprising administering a combination of TLR agonists including a TLR9 agonist as suggested by Mills and substitute ODNM362 as the TLR9 agonists as taught by Mudde with a reasonable expectation of success. The ordinary skilled artisan would have been motivated to do so as taught by Mudde because type C ODNs such as ODN362 are potent activator of Th1 type responses against allergies ([0066, 0490], see Table I) thereby advantageous for attenuating the Th2 type responses (i.e., type I hypersensitivity) in the method of Mills (see 0036-0040 of Mudde). Note that Mills teaches that the activation of Th1 type responses (including TREGs) by TLR agonists is part of the method to attenuate the Th2 responses ([0080, 0135], see Fig. 15). Hence, it would have been obvious to practice the taught method comprising the TLR2/6 agonist of PAM2CSK4 and the TLR9 agonist of ODN362, and the claimed invention as a whole was prima facie obvious in the absence of evidence to the contrary. Claim 16 is rejected under 35 U.S.C. 103 as being unpatentable over Mills et al., (US2009/0176696, filed 4/18/2007), in view of Yamazaki et al. (PLoS, 2011, 4:1-10). Krishnaswamy et al. (Am J Respir Cell Mol Bio, 2012, 47:852-863) and Mudde et al., (US2015/0196636, filed 7/02/2013), as applied to claims 1 and 14, in further view of Shirota et al., (J Imm, 2000, 164:5575-5582, see IDS filed 11/06/2023) As discussed previously, Mills et al suggests a method for attenuating type I hypersensitivity in a subject comprising administering a combination of TLR2/6 of PAM2CSK4 and TLR9 agonists. However, Mills is silent with respect to the molar ratio of TLR2/6 agonist to TLR9 agonist. Nevertheless, in regard to claim 16, Yamazaki teaches 10 nmol of the TLR2/6 agonist PAM2CSK4 is administered to the subject (p. 6, Fig. 3, legend). Furthermore, in regard to claim 16, Mudde teaches between 0.001 to 2 mg of the TLR9 agonists is administered to the subject [0136]. Since the molecular weight of ODNM362 is about 7,664 g/mol, a middle dose in the range of Mudde of about 0.02 mg would be about 2.5 nmol. Accordingly, it would have been prima facie obvious to one of ordinary skill in the art at the time of filing to practice a method for attenuating type I hypersensitivity in a subject comprising administering a combination of TLR agonists including the TLR2/6 agonist of PAM2CSK4 and the TLR9 agonist of ODNM362 as suggested by Mills et al. and to choose a dose of said TLR2/6:TLR9 agonists at a 4:1 molar ratio with a reasonable expectation of success. The ordinary skilled artisan would have been motivated to do so as taught by the known doses used for each of the components individually. In other words, Yamazaki teaches a TLR2/6 dose of about 10 nmol, and Mudde teaches a TLR9 dose of about 2.5 nmol (i.e., about 20 micrograms), thereby making obvious a 4:1 molar ratio. Although Mudde gives a range of doses in the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990). Furthermore, similar doses starting at least 10 micrograms of a TLR9 CpG-ODN agonist were known in the prior art for treating type I hypersensitivity in asthma (p. 5577, and Fig. 3 , black boxes of Shirato). It is routine procedure to optimize component amounts to arrive at an optimal product that is superior for its intended use, since it has been held where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. See M.P.E.P. §2144.05. Generally, differences in concentration will not support patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration is critical (MPEP 2144.05 II). Hence, the claimed invention as a whole was prima facie obvious in the absence of evidence to the contrary. Double Patenting The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory obviousness-type double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); and In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969). A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on a nonstatutory double patenting ground provided the conflicting application or patent either is shown to be commonly owned with this application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. Effective January 1, 1994, a registered attorney or agent of record may sign a terminal disclaimer. A terminal disclaimer signed by the assignee must fully comply with 37 CFR 3.73(b). Claims 1-19 are rejected on the grounds of nonstatutory double patenting over claims 1-9 of U.S. Patent No. 11,826,422 (Dickey et al., Patented 11/28/2023). The subject matter claimed in the instant application is fully disclosed in the referenced patent as follows: the methods and composition for treating type I hypersensitivity of cited patent anticipate the method and compositions of instant application. It is clear that all the elements of the cited patent claims are to be found in instant claims. The difference between the cited patent claims and the instant claims lies in the fact that the cited patent claims are specific to the combination of TLR9 agonist (i.e., ODNM362) and TLR 2/6 agonist PAM2CKS4. Thus the invention of said claims of the cited patent are in effect “species” of the “generic” invention of the instant claim. It has been held that the generic invention is “anticipated” by the “species”. See In re Goodman, 29 USPQ2d 2010 (Fed. Cir. 1993). Since the instant application claims are anticipated by cited patent claims, said claims are not patentably distinct. Claim 19 is rejected on the grounds of nonstatutory double patenting over claims 1-4 and 11-12 of U.S. Patent No. 10,722,573 (Dickey et al., Patented 7/28/2020). The subject matter claimed in the instant application is fully disclosed in the referenced patent as follows: the composition comprising a TLR9 agonist and a TLR2/6 agonist of cited patent anticipate the compositions of instant application. Note that instant Claim 19 is worded such that the anti-inflammatory agents is being considered as in the alternative. It is clear that all the elements of the cited patent claims are to be found in instant claims. The difference between the cited patent claims and the instant claims lies in the fact that the cited patent claims are specific to the combination of TLR9 agonist (i.e., ODNM362) and TLR 2/6 agonist PAM2CSK4. Thus the invention of said claims of the cited patent are in effect “species” of the “generic” invention of the instant claim. It has been held that the generic invention is “anticipated” by the “species”. See In re Goodman, 29 USPQ2d 2010 (Fed. Cir. 1993). Since the instant application claims are anticipated by cited patent claims, said claims are not patentably distinct. Claim 19 is rejected on the grounds of nonstatutory double patenting over claims 1-2 and 11 of U.S. Patent No. 10,286,065 (Dickey et al., Patented 5/14/2019). The subject matter claimed in the instant application is fully disclosed in the referenced patent as follows: the composition comprising a TLR9 agonist and a TLR2/6 agonist of cited patent anticipate the compositions of instant application. It is clear that all the elements of the cited patent claims are to be found in instant claims. Note that instant Claim 19 is worded such that the anti-inflammatory agents is being considered as in the alternative. The difference between the cited patent claims and the instant claims lies in the fact that the cited patent claims are specific to the combination of TLR9 agonist (i.e., ODNM362) and TLR 2/6 agonist PAM2CSK4. Thus the invention of said claims of the cited patent are in effect “species” of the “generic” invention of the instant claim. It has been held that the generic invention is “anticipated” by the “species”. See In re Goodman, 29 USPQ2d 2010 (Fed. Cir. 1993). Since the instant application claims are anticipated by cited patent claims, said claims are not patentably distinct. Claim 19 is rejected on the grounds of nonstatutory double patenting over claims 1-8 of U.S. Patent No. 9,186,400 (Dickey et al., Patented 11/17/2015). The subject matter claimed in the instant application is fully disclosed in the referenced patent as follows: the composition comprising a TLR9 agonist and a TLR2/6 agonist of cited patent anticipate the compositions of instant application. It is clear that all the elements of the cited patent claims are to be found in instant claims. Note that instant Claim 19 is worded such that the anti-inflammatory agents is being considered as in the alternative. The difference between the cited patent claims and the instant claims lies in the fact that the cited patent claims are specific to the combination of TLR9 agonist (i.e., ODNM362) and TLR 2/6 agonist PAM2CSK4. Thus the invention of said claims of the cited patent are in effect “species” of the “generic” invention of the instant claim. It has been held that the generic invention is “anticipated” by the “species”. See In re Goodman, 29 USPQ2d 2010 (Fed. Cir. 1993). Since the instant application claims are anticipated by cited patent claims, said claims are not patentably distinct. Conclusion No claims are allowed. Examiner Contact Information Any inquiry concerning this communication or earlier communications from the examiner should be directed to ARTHUR S LEONARD whose telephone number is (571)270-3073. The examiner can normally be reached on Mon-Fri 9am-5pm. If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, James Doug Schultz can be reached on 571-272-0763. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300. Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000. /ARTHUR S LEONARD/Examiner, Art Unit 1631
Read full office action

Prosecution Timeline

Oct 11, 2023
Application Filed
Mar 06, 2026
Non-Final Rejection — §102, §103, §112 (current)

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Prosecution Projections

1-2
Expected OA Rounds
51%
Grant Probability
99%
With Interview (+51.2%)
3y 6m
Median Time to Grant
Low
PTA Risk
Based on 503 resolved cases by this examiner. Grant probability derived from career allow rate.

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